Ductal Carcinoma In SituNCT00496808
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
A study testing Herceptin (Trastuzumab) in people with Ductal Carcinoma In Situ, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ductal Carcinoma In Situ
- What is being tested?
- Herceptin (Trastuzumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with histologic confirmation of DCIS (TisN0M0) that is Her-2/neu 3+ positive by immunohistochemistry (IHC) and/or positive for Her-2 gene amplification by fluorescence in situ hybridization (FISH) will be eligible for the study.
- Patients must sign informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
- Those patients with history of other contralateral non-invasive and invasive breast and non-breast malignancies are eligible to participate unless they have previously received a doxorubicin dose of more than 400 mg/m2.
- All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000 mm3. Patients must have adequate liver function, with bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine < 2.0 mg/dl.
- Patients with intact primary tumors will be eligible for this study. Patients who have had their diagnostic biopsy at an outside facility but still have measurable disease on presentation will be eligible.
- Patients with history of cardiac arrhythmia will be eligible for study after being seen by cardiology and deemed good candidates for participation.
- Women of child bearing potential must have a negative urine or serum pregnancy test.
Who cannot join
- Patients with a current known invasive breast cancer are not eligible for this study.
- All patients who are Her-2/neu negative will be ineligible for the study.
- Patients with history of congestive heart failure will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objectives:
- To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)
- To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS
Read the detailed description
Herceptin (Trastuzumab) stops or slows the growth of certain breast cancer cells by blocking the chemical signals they need to grow.
As part of your standard care for DCIS, you will have a complete routine physical exam, a mammogram of both breasts, and blood (about 2 tablespoons) will be drawn for routine tests. Some of your leftover breast biopsy tissue will be tested for Her-2/neu expression. Blood will be drawn (about 2-6 teaspoons) to check if your bone marrow (red blood cells), kidney, and liver are functioning well enough to have this treatment. Women who are able to have children must have a negative blood pregnancy test before starting treatment.
If you are eligible to take part in this study, you will receive one dose of trastuzumab at least 2 weeks before your surgery. The dose of trastuzumab will be given intravenously (through a needle in a vein in your arm) as a steady infusion over 90 minutes, on an outpatient basis. You will be checked during the infusion and for 1 hour after it is completed.
You will have routine surgery for DCIS (either segmental mastectomy, mastectomy with or without reconstruction, and possible sentinel lymph node biopsy) approximately 14 to 28 days after being given Herceptin. If a segmental mastectomy was performed as part of our standard practice you will be evaluated by a radiation oncologist following surgery. After your surgery, patients will also be evaluated by a breast medical oncologist to determine if any additional standard therapy is needed.
Tissue that is left over from the original breast biopsy and surgery will be tested for various biomarkers (substances which indicate the severity or spread of cancer), cancer growth rate, and apoptotic index (cell death rate).
This is an investigational study. The FDA has approved trastuzumab for the treatment of breast cancer. Up to 71 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Ductal Carcinoma In Situ
- Being tested
- Herceptin (Trastuzumab)
- Keywords
- Ductal Carcinoma In Situ, Breast Cancer, Herceptin, Trastuzumab, DCIS
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herceptin (Trastuzumab)Drug
Also called Trastuzumab
8 mg/kg IV Over 90 Minutes
| Study group | Role | What they receive |
|---|---|---|
| Herceptin | Experimental | 8 mg/kg intravenously (IV) Over 90 Minutes Receives: Drug: Herceptin (Trastuzumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Proliferation as Measured by Ki-67
Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.
Measured: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks
Number of Participants Achieving Documented Change in Proliferation
Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.
Measured: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks
Secondary outcomes (1)
Mean Percent of Ki-67
Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.
Measured: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startMar 2005
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry Kuerer, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496808
- Sponsor's protocol ID
- 2004-0701
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2007
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
- ClinicalTrials.gov ID
- NCT00496808
- Acronym / sponsor ID
- 2004-0701
- Conditions
- Ductal Carcinoma In Situ
- Keywords
- Ductal Carcinoma In Situ, Breast Cancer, Herceptin, Trastuzumab, DCIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 18 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)
- To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS
Detailed description
Herceptin (Trastuzumab) stops or slows the growth of certain breast cancer cells by blocking the chemical signals they need to grow.
As part of your standard care for DCIS, you will have a complete routine physical exam, a mammogram of both breasts, and blood (about 2 tablespoons) will be drawn for routine tests. Some of your leftover breast biopsy tissue will be tested for Her-2/neu expression. Blood will be drawn (about 2-6 teaspoons) to check if your bone marrow (red blood cells), kidney, and liver are functioning well enough to have this treatment. Women who are able to have children must have a negative blood pregnancy test before starting treatment.
If you are eligible to take part in this study, you will receive one dose of trastuzumab at least 2 weeks before your surgery. The dose of trastuzumab will be given intravenously (through a needle in a vein in your arm) as a steady infusion over 90 minutes, on an outpatient basis. You will be checked during the infusion and for 1 hour after it is completed.
You will have routine surgery for DCIS (either segmental mastectomy, mastectomy with or without reconstruction, and possible sentinel lymph node biopsy) approximately 14 to 28 days after being given Herceptin. If a segmental mastectomy was performed as part of our standard practice you will be evaluated by a radiation oncologist following surgery. After your surgery, patients will also be evaluated by a breast medical oncologist to determine if any additional standard therapy is needed.
Tissue that is left over from the original breast biopsy and surgery will be tested for various biomarkers (substances which indicate the severity or spread of cancer), cancer growth rate, and apoptotic index (cell death rate).
This is an investigational study. The FDA has approved trastuzumab for the treatment of breast cancer. Up to 71 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herceptin | Experimental | Drug: Herceptin (Trastuzumab)8 mg/kg intravenously (IV) Over 90 Minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- All patients with histologic confirmation of DCIS (TisN0M0) that is Her-2/neu 3+ positive by immunohistochemistry (IHC) and/or positive for Her-2 gene amplification by fluorescence in situ hybridization (FISH) will be eligible for the study.
- Patients must sign informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
- Those patients with history of other contralateral non-invasive and invasive breast and non-breast malignancies are eligible to participate unless they have previously received a doxorubicin dose of more than 400 mg/m2.
- All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000 mm3. Patients must have adequate liver function, with bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine < 2.0 mg/dl.
- Patients with intact primary tumors will be eligible for this study. Patients who have had their diagnostic biopsy at an outside facility but still have measurable disease on presentation will be eligible.
Key exclusion criteria (3 listed)
- Patients with a current known invasive breast cancer are not eligible for this study.
- All patients who are Her-2/neu negative will be ineligible for the study.
- Patients with history of congestive heart failure will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herceptin (Trastuzumab)Also: Trastuzumab8 mg/kg IV Over 90 Minutes | Drug | Herceptin |
Primary outcome
Percent Change in Proliferation as Measured by Ki-67
Time frame: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks
Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.
Number of Participants Achieving Documented Change in Proliferation
Time frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks
Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.
1 secondary outcome
Mean Percent of Ki-67
Time frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Kuerer, MD, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herceptin (Trastuzumab) in people with Ductal Carcinoma In Situ, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Proliferation as Measured by Ki-67 (time frame: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.